Manufacturing Partnerships: Don’t Underestimate the Importance of Collaboration
Tim Hirst, CEO of GPN Vaccines, recently spoke with Outsourced Pharma about how BioCina quickly developed a new manufacturing process for their groundbreaking pneumococcal vaccine. Read the article in Outsourced Pharma: Click here
When selecting a CDMO, the most important traits to consider are speed, collaboration, and regulatory compliance. In biologics manufacturing, time is money. Most developers don’t have the time or the overhead to take their product to manufacturing alone. This is where an effective CDMO partnership comes in.
BioCina owns and operates a former FDA-approved Pfizer facility and complies with cGMP manufacturing (current good manufacturing practice) regulations. We’re set up to quickly onboard developers and produce complex microbial and plasmid DNA products. But successful projects rely on more than just facilities. Regular, consistent communication and an agile approach to manufacturing can make all the difference.
Consider our recent work with GPN Vaccines, for example. GPN Vaccines came to BioCina to manufacture their new revolutionary pneumococcal vaccine (which has the potential to save up to two million lives each year). The bacteria they used to make their vaccine, Streptococcus pneumoniae, is not commonly used among microbial CDMOs. BioCina worked closely with GPN Vaccines to develop a manufacturable vaccine suitable for human clinical trials.
Let’s dive deeper into what made this partnership successful.
Speed & Agility
BioCina understood that GPN Vaccines needed to get the manufactured vaccine tested in toxicology studies as quickly as possible. Only then would the product be proven safe and ready to progress to a clinical trial. This expectation was established early, and GPN and BioCina were on the same page from the very first step.
This project was fast and only took ten months from onboarding to a suitable clinical batch. This type of relationship doesn’t happen by default; budgets and expectations must be established up front and revisited continuously throughout the project. You need the right team and an entrepreneurial spirit to solve problems, figure out what’s optimal, and make decisions quickly to get a satisfactory outcome.
BioCina is not only a manufacturer but a flexible developer of robust product manufacturing processes.
Collaboration & Communication
Collaboration and consistent communication are vital to sustaining a strong partnership between developers and CDMO. Each party needs to be aware of the project’s expectations and current standing. Only then can a manufacturing process be devised, optimized, and implemented.
Throughout the project, BioCina produced several batches of the vaccine and shipped them to GPN for rapid analysis and feedback. We also held weekly meetings to discuss the latest results and improve the manufacturing process over multiple iterations.
Both teams understood this project’s goals and importance. A pneumococcal vaccine has huge implications for patients worldwide. With that in mind, each member knew the importance of their work in bringing this vaccine to clinical trials. Ultimately, strong project management and open communication led this project to success. It wasn’t a simple contract but rather a truly collaborative partnership.
Why BioCina (and Australia)?
BioCina is your partner for high-quality, cost-effective microbial process development and cGMP manufacturing solutions for recombinant proteins and GMP plasmid DNA. Our professional and experienced project management team will guide the efficient development, delivery, and supply of all your contract development and cGMP manufacturing requirements.
But why develop your product in Australia? The Australian Government offers generous R&D tax incentives. Receive up to 43% cash back for eligible R&D expenditures, including clinical trials, analytics, and study drug manufacturing.
What’s more, you could save six to nine months waiting for regulatory approval. The average regulatory approval time is only six weeks. There’s also no Investigational New Drug (IND) requirement. Learn more about the advantages of developing and manufacturing biopharmaceuticals in Australia here.
BioCina is licensed by the Australia TGA and is currently the only microbial drug substance facility of its kind in Australia approved by the US-FDA. The site also has supported product approvals in Europe and other highly regulated markets.
Learn more about BioCina’s comprehensive development and manufacturing services here.